Big Pharma Forms Consortium for Drug Safety

The heads of R&D from several major pharmaceutical companies have established a consortium to find a molecular basis for serious adverse reactions to drugs.

The group, known as the International Serious Adverse Events Consortium (SAEC), will focus first on drug-induced liver injury and severe skin rashes (particularly Stevens-Johnson Syndrome and toxic epidermal narcosis).

"We want to find out if there are clear genetic factors that increase risk when presented with a variety of drugs that could cause an individual to have an adverse event," says SAEC founder, chairman, and CEO Arthur Holden.

"It may not be that the drug is unsafe—it may be that it is unsafe for a particular individual, but safe for many others. If we could understand, identify, and validate these markers, then it could be a phenomenal breakthrough in the productivity of the lifecycles and therapeutics industries."

According to Holden, the skin disorders to be studied are associated with more than 200 medicines, and acute liver failure with nearly 50 different types of drugs. The data for the skin disorder cases will be contributed by GSK, and the liver injury cases are from a group of European pharma companies. "We will be characterizing both the cases from each cohort with 1,000 match controls using different race and gender parameters that have not exhibited an adverse reaction," Holden said.

All data will be deposited into a data-coordinating center at Columbia University to be analyzed collaboratively. Clinical data will be made available to qualified researchers through a Web site. "We intend to publish information free of intellectual product restraints, because we want people to use the information as primary markers for safety," Holden said.

Consortium Conception
The roots of the SEAC consortium can be dated back to 1999, with an effort to map variance in the human genome, dubbed the Single Nucleotide Polymorphism (SNP) Consortium. The group identified almost 3 million common mutations, which laid down the foundation of genotyping and genomic analysis to look at disease susceptibility and drug response.

According to Holden, "The core enabling platform to move genotyping forward was done by the pharmaceutical industry and contributed into the public domain—it helped set up the architecture for the publicly available SNP data."

The success of the program encouraged Holden to return to the industry for his new project.

"The biggest challenge is always one of orchestration on a timely basis," Holden says. "This is a field that will fundamentally move forward through open collaboration, and anyplace where you have a resistance to collaboration might take a little longer. We need to see past parochial interests and realize the benefits of working in a larger, more aggressive network."